CSL’s Quality Management System consists of an independent Quality Assurance function along with a Quality Operations group that is a part of the Clinical development organisation. Together, the two groups provide the foundation for a risk-based, proactively managed Quality System across Global Clinical development that ensures regulated clinical trial activities are:

• Conducted with a high level of quality; 
• Conducted according to regulatory requirements; 
• Consistent with industry best practices; 

These objectives are achieved through:

• Maintenance of a robust set of written standard operating procedures (SOPs) with staff adequately trained against them;
• A compliance monitoring program to ensure adherence to the SOPs and drive inspection readiness; 
• A well-defined Corrective Action/Preventive Action (CAPA) management process that promotes a systematic approach to dealing with critical/major issues and enabling study teams to effectively apply real-time lessons learned; 
• Execution of audits on our investigative sites, vendors, and internal processes/systems.

To this end, CSL is committed to:

• The prospective registration on a publicly available trial registry of all CSL-sponsored clinical trials and applicable observational/non-interventional studies (NIS); and
• The reporting of results of completed CSL-sponsored clinical trials and applicable observational studies/NIS on a results database or equivalent website, according to regulatory requirements. Results are made publically available, regardless of outcome.

The pharmaceutical industry as a whole is working towards providing greater levels of public access to clinical trial data. CSL has in place policies and procedures that ensure our disclosures will be compliant, at the very minimum, with the emerging requirements. In Europe, current requirements allow for the regulatory authority to release detailed information, including Clinical Study Reports and summary reports following agency decision on drug applications. CSL supports the release of those documents in full, including appendices, provided proprietary information and information that could compromise patient anonymity are redacted in line with relevant data protection legislation. Furthermore, as these requirements evolve globally, CSL will continue efforts to comply in a timely manner with national and international statutory requirements regarding disclosure of individual patient data and the right of patients to privacy.